SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of
FDA device recall Z-1396-2010 · posted 2010-04-15 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc., dba Datascope Patient Monitoring
- Reason for recall
- SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.
- Action taken
- Mindray DS USA, Inc. issued an "Urgent Product Recall" notification dated December 31, 2009 by certified mail. Consignees were informed of the affected product and requested to discard all remaining stock. Replacement product will be provided by the firm at no cost. For further information, contact Mindray DS USA, Inc. at 1-201-995-8000.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DXN
- Quantity affected
- Total: 33,976 boxes of 20 (boxes of 20 packaged into boxes of 200) in US, 801 boxes OUS
- Distribution
- Worldwide Distribution -- United States, Canada and Australia. Nationwide distribution to hospitals, medical facilities and distributors as well as to Canada and Australia.
- Date initiated
- 2009-12-31
- Date posted
- 2010-04-15
- Date terminated
- 2011-12-09
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCUTORR V MONITOR, MODEL 0998-00-2000 (K091068) | Datascope Corp., Patient Monitoring Division | 2009-05-08 |